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The study examined secukinumab biosimilar lentivirus-based gene therapy, which showed successful and prolonged expression of the recombinant antibody in rats.

The Center for Biosimilars® recaps the top stories for the week of January 20, 2020.

Pfizer said it expects its 3 oncology biosimilar products to have the lowest wholesale acquisition cost among currently available bevacizumab, rituximab, or trastuzumab biosimilars. Its latest, Ruxience, referencing Rituxan, launched Thursday.

Health New England says it achieved 93% utilization by requiring prior authorization.

Increasing trust in generics and biosimilars, and assuring their timely entry into the market, will yield greater benefit from these lower-cost options, according to a recent review.

In May 2019, the FDA released its final guidance on biosimilars. With more and more oncology biosimilars entering the market, healthcare providers should be able to help their patients reduce their out-of-pockets costs while providing the highest-quality care available, which will lead to savings over time, according to a recent column in Evidence-Based Oncology™, a sister publication to The American Journal of Managed Care®.

The Center for Biosimilars® recaps the top stories for the week of January 13, 2020.

The biosimilar CPT-13 (Remsima) is currently approved in Europe for all uses for which the originator infliximab (Remicade) is approved, including Crohn disease (CD) and ulcerative colitis (UC), which are often referred to collectively as IBD.

The current market value of the branded sales for these biosimilars is estimated to exceed $2 billion annually, the companies said.

An accompanying editorial describes the current regulatory process as “a thicket of special programs, flexible review criteria, and generous incentives,” and suggests starting points for reforms, including improving access to biosimilars.

In the United States, recent analyses show that biosimilars achieved just 9%, or $91 million, of the $1 billion in cost savings that the Congressional Budget Office projected 10 years ago.

The final report includes voting results from a December 2019 meeting of one of ICER’s independent evidence appraisal panels, the California Technology Assessment Forum (CTAF), plus policy recommendations from an expert roundtable.

The Center for Biosimilars® recaps the top stories for the week of January 6.

It is the only biosimilar candidate referencing Soliris to be granted investigational new drug approval in China.

It is the first adalimumab biosimilar approved by the China National Medical Products Administration.

The study follows others that have found that SB4 works well for the majority of patients who switched from the originator etanercept, Enbrel.

Two studies recently reported on Hulio, the adalimumab biosimilar marketed and developed by Mylan and its partner Fujifilm Kyowa Kirin Biologics.

The law made California the first state to bar pay-for-delay pharmaceutical agreements by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company.

The Innovation and Value Initiative (IVI) has updated its existing prototype economic model examining value among rheumatoid arthritis (RA) therapies to include biosimilars.

In 2019 the FDA approved 48 novel drugs and 10 biosimilars, according to the Center for Drug Evaluation and Research (CDER).

Just 6% of the Asian doctors said they felt confident using biosimilars in clinical practice. A survey of European doctors found a similar confidence level in 2013, but that level had climbed to 28.8% by 2015.

Sorrento Therapeutics said this week it plans a 2020 Biologics License Application in the United States for a “biobetter” of infliximab.

Novo Nordisk said 3 measures to make insulin more affordable are now available, and it also announced that the FDA expanded use of its fast-acting mealtime insulin to children as young as 2.

Indian private equity firm True North could soon hold a 2.44% minority stake in Biocon Biologics India Ltd, a subsidiary of Biocon Ltd, thanks to a $100-million investment. The influx of cash values Biocon Biologics at close to $3 billion. The investment is pending regulatory approval.

Zirabev, which references Avastin, will be priced at a wholesale acquisition cost (WAC) of $61.34 per 10 mg, representing a 23% discount to the WAC of Avastin, Pfizer said.

In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.

The findings indicate that interventions that leverage physician relationships may assist with increasing uptake of new, high-value cancer treatments in place of low-value therapies.

Using the biosimilar resulted in a significantly lower drug acquisition cost, at $533.40 in the biosimilar group versus $1261.90 in the reference group.

The Center for Biosimilars® recaps the top stories for the week of December 30, 2019.

Last month, Gilead Sciences submitted a New Drug Application (NDA) to the FDA for filgotinib under the priority review process. Filgotinib is a Janus kinase (JAK) inhibitor aimed at moderate-to-severe rheumatoid arthritis (RA).